Device Classification Name |
device, vascular, for promoting embolization
|
510(k) Number |
K151358 |
Device Name |
AZUR CX Detachable 35 Coils |
Applicant |
Micro Vention, Inc. |
1311 Valencia Avenue |
Tustin,
CA
92780
|
|
Applicant Contact |
Cynthia Valenzuela |
Correspondent |
Micro Vention, Inc. |
1311 Valencia Avenue |
Tustin,
CA
92780
|
|
Correspondent Contact |
Cynthia Valenzuela |
Regulation Number | 870.3300
|
Classification Product Code |
|
Date Received | 05/20/2015 |
Decision Date | 09/25/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|